Area Under the Curve (0-t) of Plasma Metformin [ Time Frame: Time points at which data were collected to create the area under the curve (0-t) for plasma metformin were: t = -0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 11 h relative to the start time of the standardized breakfast. ] [ Designated as safety issue: No ]

Measures from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration. The dose of study medication was administered at t = -1 min relative to the start time of the standardized breakfast.

Surgically sterile, postmenopausal, or if of childbearing potential, must practice and be willing to continue to practice appropriate birth control during the entire duration of the study

Has a physical examination with no clinically significant abnormalities as judged by the investigator.

Ability to understand and willingness to adhere to protocol requirements.

If on chronic thyroid pharmacologic therapy, the dose must be stable for at least 3 months prior to Visit 1 (Screening), and must have thyroid-stimulating hormone (TSH) test result in normal range at Visit 1 (Screening).

Exclusion Criteria:

Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:

Hepatic disease

Renal disease

Gastrointestinal disease

Endocrine disorder except diabetes

Cardiovascular disease

Seizure disorder

Organ transplantation

Chronic infection

Has any chronic disease requiring medication that has been adjusted in the past 90 days (subjects may take acute intermittent over-the-counter medications such as Tylenol, if needed).

Has any drug treatment that affects gastric pH (prescription or over-the-counter), including any antacids or medications such as Rolaids or Pepcid within 2 days of Visit 1 (Screening).

Has had major surgery of any kind within 6 months of Visit 1 (Screening).

Has received a blood transfusion within 6 months of Visit 1 (Screening).

Has a history of >5 kg weight change within 3 months of Visit 1 (Screening).

Has clinical laboratory test (clinical chemistry, hematology, or urinalysis) abnormalities other than those expected in subjects with diabetes and judged by the investigator to be clinically significant at Visit 1 (Screening).

Has physical, psychological, or historical finding that, in the investigator's opinion, would make the subject unsuitable for the study.

Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant with study procedures.

Has donated blood within 2 months of Visit 1 (Screening) or is planning to donate blood during the study.

Has received any investigational drug within 1 month (or five half-lives of the investigational drug, whichever is greater) of Visit 1 (Screening).

Has known allergies or hypersensitivity to any component of study treatment.

Is employed by Elcelyx Therapeutics, Inc (that is an employee, temporary contract worker, or designee of the company).

Smokes more than 10 cigarettes per day, 2 cigars per day, or uses more than 1 can of smokeless tobacco per week.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677299